SkylineDx received FDA Breakthrough Device Designation for its Merlin CP-GEP assay, a clinicopathologic gene expression profiling test for early-stage cutaneous melanoma risk assessment. The test supports clinical decision-making around sentinel lymph node biopsy selection and follow-up discussions by stratifying patients into high- and low-risk groups for metastasis. SkylineDx said the designation was supported by data from the MERLIN_001 trial, and that the assay has been developed with Mayo Clinic. The company noted that NCCN guidelines recognize the test as predictive gene expression profiling, which may be used for risk assessment in T1b and T2a disease.